FDA.reportPublic FDA data

body-jet evo

Primary DI
04260170881328
Brand
body-jet evo
Company
Human Med AG
Model
body-jet evo liposuction device, 120 V, 60 Hz, 65
Catalog number
500000-17
Device description
body-jet evo device, for Water-jet Assisted Liposuction, 120 V, 60 Hz, 6A, 65 kg, IP 22
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082025000BODY-JETHuman Med AG2008-08-13QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260170881328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260170881328042601708813284260170881328

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction systemAn assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49385395700info@humanmed.com

Regulatory Flags#

DUNS number
332719157
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260170880048WAL applicatorSingle-use WAL Applicator for body-jet, L=300500001-52025-07-30
04260170880505WAL applicatorSingle-use WAL Applicator, Short, L=300, for 20 cm500001K-52025-07-30
04260170880826WAL CannulaSingle-use, Ø=3.8, L=300, 4H, Extraction1500125-52025-07-30
04260170880864WAL CannulaSingle-use, Ø=4.8, L=300, 4H, Extraction1500136-52025-07-30
04260170880888WAL CannulaSingle-use, Ø=4.2, L=300, 4H, Extraction1500148-52025-07-30
04260170880901WAL CannulaSingle-use, Ø=3.8, L=300, 4H, Extraction1501125-52025-07-30
04260170880925WAL CannulaSingle-use, Ø=3.8, L=300, 3H, Extraction, Subcutan1502004-52025-07-30
04260170880949WAL CannulaSingle-use, Ø=3.8, L=300, 8H, Extraction1503004-52025-07-30
04260170880963WAL CannulaSingle-use, Ø=4.8, L=300, 8H, Extraction1503005-52025-07-30
04260170881007Biofill CannulaSingle-use, Ø=3.5, L=150, 4H, Extraction1580089-52025-07-30
04260170881021Biofill Infiltration CannulaSingle-use, Ø=2.5, L=150, 0H, Infiltration1580107-52025-07-30
04260170881045Biofill CannulaSingle-use, Ø=3.8, L=150, 4H, Extraction1580125-52025-07-30
04260170881069Biofill CannulaSingle-use, Ø=3.8, L=150, 4H, Rapid, Extraction1581125-52025-07-30
04260170881083FillerCollectorSingle-use FillerCollector, 250ml, Collect Fat1660000-52025-07-30
04260170881113Q-graft collectorSingle-use Q-graft collector3000012025-07-30
04260170881137WAL Infiltration CannulaSingle-use, Ø=2.5, L=200, 0H, 180°, Infiltration1500114-52025-07-30
04260170881144WAL applicator, 370 cmSingle-use WAL Applicator for body-jet evo, L=370,570001-52025-07-30
04260170881151Biofill applicatorSingle-use Biofill Applicator for body-jet evo and580001-52025-07-30
04260170881373Disposable Set FillerCollectorSingle-use Disposable Set for Re-usable FillerColl6600232025-07-30
04260170881403Disposable Set LipoCollector IIISingle-use Disposable Set for Re-usable LipoCollec6702002025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329838225BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.QPB2026-06-08
00607151051006AYON™ Power Liposuction Tubing AdaptorAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057008AYON™ Power Liposuction HandpieceAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057015AYON™ Power Liposuction CableAPYX MEDICAL CORPORATIONQPB2026-05-14
08800028800031LSSA (NP-200)NewpongQPB2026-05-06
03701416200035EUROMIEuromiQPB2025-08-27
03701416203388EUROMIEuromiQPB2025-08-27
03701416203401EUROMIEuromiQPB2025-08-27
00847399017413MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017420MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017437MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017444MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017451MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017468MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017475MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017482MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017499MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017505MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017512MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399018960MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
04260170880048WAL applicatorHuman Med AGQPB2025-07-30
04260170880505WAL applicatorHuman Med AGQPB2025-07-30
04260170880826WAL CannulaHuman Med AGQPB2025-07-30
04260170880864WAL CannulaHuman Med AGQPB2025-07-30
04260170880888WAL CannulaHuman Med AGQPB2025-07-30
04260170880901WAL CannulaHuman Med AGQPB2025-07-30
04260170880925WAL CannulaHuman Med AGQPB2025-07-30
04260170880949WAL CannulaHuman Med AGQPB2025-07-30
04260170880963WAL CannulaHuman Med AGQPB2025-07-30
04260170881007Biofill CannulaHuman Med AGQPB2025-07-30